scholarly journals Development and use of in vitro alternatives to animal testing by the pharmaceutical industry 1980–2013

2015 ◽  
Vol 4 (5) ◽  
pp. 1297-1307 ◽  
Author(s):  
Jen-Yin Goh ◽  
Richard J. Weaver ◽  
Libby Dixon ◽  
Nicola J. Platt ◽  
Ruth A. Roberts
Keyword(s):  
Pharmaceutical Industry ◽  
Animal Testing ◽  
Genetic Toxicology ◽  
Safety Testing ◽  
Safety Pharmacology ◽  
Alternatives To Animal Testing ◽  
Ich Guidelines ◽  
Preclinical Safety

An analysis of the use ofin vitrotechniques in preclinical safety testing revealed a marked increase to >180 000 tests/year by 2012. Step changes in uptake were notable in the three main areas of ADME, safety pharmacology and genetic toxicology, correlated with relevant ICH guidelines.

Integrated Decision-tree Testing Strategies for Skin Corrosion and Irritation with Respect to the Requirements of the EU REACH Legislation

2008 ◽  
Vol 36 (1_suppl) ◽  
pp. 65-74
Author(s):  
Christina Grindon ◽  
Robert Combes ◽  
Mark T.D. Cronin ◽  
David W. Roberts ◽  
John F. Garrod
Keyword(s):  
Alternative Methods ◽  
The European Union ◽  
Testing Strategy ◽  
Animal Testing ◽  
Safety Testing ◽  
Alternatives To Animal Testing ◽  
Testing Strategies ◽  
The Status ◽  
The Eu

Liverpool John Moores University and FRAME recently conducted a research project, sponsored by Defra, on the status of alternatives to animal testing with regard to the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals. The project covered all the main toxicity endpoints associated with the REACH system. This report focuses on how to maximise the use of alternative methods (both in vitro and in silico) for skin corrosion and irritation testing within a tiered testing strategy. It considers the latest developments in in vitro testing, with particular reference to the reconstituted skin models which have now been now been successfully validated and independently endorsed as suitable for both skin corrosivity and irritancy testing within the EU.

Research on the development of alternatives to animal testing for pharmaceutical products and international standardisation

Impact ◽  
2021 ◽  
Vol 2021 (8) ◽  
pp. 44-45
Author(s):  
Hajime Kojima
Keyword(s):  
Research Group ◽  
Pharmaceutical Products ◽  
In Vitro Assays ◽  
Animal Testing ◽  
3 Dimensional ◽  
Alternatives To Animal Testing ◽  
Gene Assay ◽  
Innovative Work ◽  
Regulatory Acceptance

Scientists are working to develop new and innovative alternatives to animal testing that don't rely on the use of animals. Takao Ashikaga, Hajime Kojima and Yoko Hirabayashi are part of JaCVAM which works to promote the use of alternatives to animal testing. The goal is to replace, reduce or refine (3Rs) the use of animal under International harmonization. Hirabayashi is also the representative of a research group that is funded by the AMED and the representative of a research group funded by the MHLW. A challenge the researchers are facing in their quest to ensure the welfare of experimental animals and also ensure the safety of various pharmaceutical and chemicals is the lack of biomarkers to more accurately predict toxicity for regulatory acceptance. This means that without animal testing more costly and complex non-animal methods are required and presents a barrier to the adoption of non-animal methods for international standerisation. As such, there is a need to develop an easy way to obtain a lot of information. Hirabayashi and the team are working on the development of AI that can be used to evaluate the safety of different compounds. The researchers are developing in vitro assays such as ordinary 2-dimensional culture, 3-dimensional culture including organoids or spheroids, reporter gene assay and organ-on-a chip; and in silico assays such as computer toxicology using QSAR and Read Across. The researchers hope that their innovative work will contribute to the 3Rs, benefiting animal welfare for regulatory use.

In Vitro Methods: Alternatives to Animal Testing

2019 ◽  
pp. 447-457
Author(s):  
Dayane Pifer Luco ◽  
Vânia Rodrigues Leite-Silva ◽  
Heather A.E. Benson ◽  
Patricia Santos Lopes
Keyword(s):  
Animal Testing ◽  
In Vitro Methods ◽  
Alternatives To Animal Testing

2018 Lush Science Prize

2020 ◽  
Vol 48 (1_suppl) ◽  
pp. 18S-25S
Author(s):  
Jenny McCann ◽  
Terry McCann
Keyword(s):  
Public Awareness ◽  
Relevant Literature ◽  
Toxicity Testing ◽  
In Vitro Assays ◽  
Adverse Outcome Pathway ◽  
Annual Conference ◽  
Animal Testing ◽  
Safety Testing ◽  
Animal Replacement

The Lush Prize supports animal-free testing by awarding money prizes of up to £350,000 per year to the most effective projects and individuals who have been working towards the goal of replacing animals in product or ingredient safety testing. Since its inception in 2012, the Lush Prize has distributed almost £2 million. Prizes are awarded for developments in five strategic areas: Science; Lobbying; Training; Public Awareness; and Young Researchers. In 2015, the judges also awarded a Black Box prize for the development of the skin sensitisation Adverse Outcome Pathway and its associated in vitro assays. The Science Prize is awarded to researchers whose work the judging panel believe to have made the most significant contribution, in the preceding year, to the replacement of animal testing. This 2018 Science Background paper outlines the research projects that were presented to the Prize judges as potential candidates for the 2018 Lush Science Prize award. To obtain an overview of developments in the field of animal replacement in toxicity research, recent work by the relevant scientific institutions and projects in this area, including the OECD, CAAT, ECVAM, UK NC3Rs, US Tox21 Programme, the ToxCast programme and EU-ToxRisk, was reviewed. Recent developments in toxicity testing research were investigated by searching the relevant literature. Abstracts from conferences focusing on animal replacement in toxicity testing that were held in the preceding 12 months, were also analysed, including those from the 2017 10th World Congress on Alternatives and Animals in the Life Sciences and the 2018 Society of Toxicology annual conference.

In vitro pituitary and thyroid cell proliferation assays and their relevance as alternatives to animal testing

2013 ◽  
Vol 221 ◽  
pp. S151
Author(s):  
Barae Jomaa ◽  
Jac M.M.J.G. Aarts ◽  
Laura H.J. de Haan ◽  
Ad A.C.M. Peijinenburg ◽  
Toine F.H. Bovee ◽  
...  
Keyword(s):  
Cell Proliferation ◽  
Thyroid Cell ◽  
Animal Testing ◽  
Alternatives To Animal Testing ◽  
Proliferation Assays

A new 3D model for genotoxicity assessment: EpiSkin™ Micronucleus Assay

Mutagenesis ◽  
2020 ◽  
Author(s):  
Lizao Chen ◽  
Nan Li ◽  
Yanfeng Liu ◽  
Brigitte Faquet ◽  
Nathalie Alépée ◽  
...  
Keyword(s):  
Task Force ◽  
Basal Layer ◽  
Micronucleus Assay ◽  
Test Method ◽  
Correct Identification ◽  
Animal Testing ◽  
Vitro Assay ◽  
European Regulation ◽  
Safety Testing

Abstract The European Regulation on Cosmetics (no. 1223/2009) has prohibited the use of animals in safety testing since March 2009 for ingredients used in cosmetics. Irreversible events at the chromosome level (clastogenesis and aneugenesis) are commonly evaluated by scoring either micronuclei or chromosome aberrations using cell-based genotoxicity assays. Like most in vitro genotoxicity assays, the 2D in vitro micronucleus assay exhibits a poor specificity and does not mimic the dermal route. To address these limitations, the current project aims to develop and validate a 3D micronucleus assay using the EpiSkin™ model. This project is scientifically supported by the Cosmetics Europe Genotoxicity Task Force. In a first step, two key criteria for the development of micronucleus assay, namely, the sufficient yield of cells from the EpiSkin™ model and an acceptable proliferation rate of the basal layer, were assessed and demonstrated. Subsequently, six chemicals (vinblastine, n-ethylnitrosourea, β-butyrolactone, 2-acetylaminofluorene, 2,4-dichlorophenoland d-limonene) were evaluated in the EpiSkin™ Micronucleus Assay. At least two independent experiments using 48- and 72-h incubations were performed for each chemical. Results showed good inter-experimental reproducibility, as well as the correct identification of all six tested chemicals. The metabolism of 2-acetylaminofluorene on the EpiSkin™ model was also investigated and confirmed by the formation of an intermediate metabolite (2-aminofluorene). These preliminary results from the EpiSkin™ Micronucleus Assay indicate that it is a promising in vitro assay for assessing genotoxicity. The availability and suitability of this test method contribute significantly to the development of non-animal testing methods in China and its impact on the worldwide field.

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